PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 000 INITIAL COMMENTS PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 000 A Federal Allegation survey was conducted on October 9-11 and October 15-18, 2019. The facility was found to be out of compliance with 42 CFR Part 482, Subpart E, Medicare Conditions of Participation (CoP) for Transplant Centers, for these Complaint Investigations: Complaint Numbers NJ00128975, NJ00129270, NJ00129297 and NJ00129943. Condition and Standard level deficiencies were evident. The following Conditions of Participation (CoPs) were out of compliance: 482.96 Quality Assessment and Performance Improvement 482.102 Patient and Living Donor Rights An Immediate Jeopardy (IJ) was called related to Quality Assessment and Performance Improvement (QAPI). The facility identified adverse events, but failed to implement corrective measures to ensure that similar future adverse events did not reoccur. The facility was notified of the IJ on December 12, 2019 at 2:34 PM. Definitions: Adult Heart- Only (AHO) Adult Lung- Only (ALO) HR- Heart Recipient LR- Lung Recipient X 001 SPECIAL REQUIREMENTS FOR TRANSPLANT CENTERS CFR(s): 482.68 AHO X 001 LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE (X6) DATE TITLE Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients . (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 1 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 001 Continued From page 1 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 001 ALO A transplant center located within a hospital that has a Medicare provider agreement must meet the conditions of participation specified in §482.72 through §482.104 in order to be granted approval from CMS to provide transplant services. (a) Unless specified otherwise, the conditions of participation at §482.72 through §482.104 apply to heart, heart-lung, intestine, kidney, liver, lung, and pancreas centers. (b) In addition to meeting the conditions of participation specified in §482.72 through §482.104, a transplant center must also meet the conditions of participation specified in §482.1 through §482.57. This CONDITION is not met as evidenced by: Based on staff interview and document review, it was determined that the facility's AHO and ALO programs failed to meet the required Medicare Conditions of Participation (CoPs) for Quality Assessment and Performance Improvement (QAPI), and Patient Rights. Findings include: The following Medicare Conditions of Participation (CoPs) are not in compliance: 482.96: Quality Assessment / Performance Improvement (Cross refer to tag X 099, X 101, X 103, and X 104) 482.102: Patient and Living Donor Rights (Cross refer to tag X 149, and X 152) FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 2 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 073 Continued From page 2 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 073 X 073 X 073 ORGAN RECEIPT CFR(s): 482.92(b) AHO After an organ arrives at a transplant center, prior to transplantation, the transplanting surgeon and another licensed health care professional must verify that the donor's blood type and other vital data are compatible with transplantation of the intended recipient. This STANDARD is not met as evidenced by: Based on medical record review, staff interview, and review of facility policy, it was determined that the facility failed to ensure all donor and candidate compatibility is completed at the time of organ receipt, in the Operating Room (OR), in one (1) of six (6) medical records reviewed (Medical Record #2) for organ verification. Findings include: Reference: Facility Policy #02, titled, "Multidisciplinary Team Roles in all Phases of Transplant" states, "... Multidisciplinary Team Roles and Responsibilities ... Transplant Surgeon ... [bullet] Transplant Phase responsibilities include but are not limited to ..., verifying donor and candidate compatibility, ..." 1. Medical Record LR #2 contained documentation on the 'PRE-TRANSPLANT VERIFICATION -UPON ORGAN RECEIPT' form, that a single lung was received in the OR on 9/19/19 at 14:02. The verification date and time was 9/19/19 at 11:15. The documentation reflects the organ was verified two (2) hours and 47 minutes prior to its arrival to the OR. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 3 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 073 Continued From page 3 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 073 2. The above was reviewed with and confirmed by Staff #59 on 10/17/19 at 4:19 PM. X 087 PATIENT RECORDS CFR(s): 482.94(c) X 087 AHO Transplant centers must maintain up-to-date and accurate patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation. This STANDARD is not met as evidenced by: Based on medical record review, it was determined that the facility failed to ensure all medical records are accurate and complete for each patient who receives an evaluation for placement on the transplant center's waiting list, and is admitted for organ transplantation in two (2) of twenty (20) records reviewed (Medical Records #4 and #5). Findings include: 1. Patient AHO #4's pre-transplant inpatient and outpatient medical records were reviewed. The following was evident: a. The patient's first encounter to the facility was for his/her admission on 3/28/14, when he/she was transferred to this facility from another hospital. The facesheet contained documentation that his/her date of birth was "10/11/1957." b. The 'Adult Nutrition Reassessment/Plan' dated 4/3/14 contained documentation under 'Nutritional Risk Factors Grid' of the patient's, "Age: Yes, 62 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 4 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 087 Continued From page 4 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 087 years old." Patient AHO #4's date of birth was 10/11/1957 and his/her age at the time of the nutritional reassessment was 57 years old. c. Patient AHO #4 was admitted to the facility on 10/28/14 and was discharged on 10/29/14. A 'SHORT STAY HISTORY & PHYSICAL FORM' dated 10/27/14 contained documentation indicating the patient's date of birth was "10/11/1951." The patient's date of birth is 10/11/1957. d. Patient AHO #4 had an outpatient cardiac catheterization procedure on 12/3/2015. A 'SHORT STAY HISTORY & PHYSICAL FORM' dated 12/3/2015 contained documentation indicating the patient's date of birth is "10/11/1951." The patient's date of birth is 10/11/1957. 2. Patient HR #5, a 60 year old male with a history of heart failure and LVAD (left ventricular assist device) was admitted to the facility on 4/5/18 for open heart transplant (OHT), after a donor was identified. Per the facesheet, the patient's date of birth was 8/19/1957. a. Upon review of the medical record, the following inaccurate documentation was revealed: (i) The "ADVANCED HEART FAILURE INITIAL EVALUATION," dated 4/5/18 stated, " ...58 year old male ...". The patient was 60 years old. (ii) The "Progress Note-Physician," dated 4/6/18 at 2:11 AM, stated, " ...58 year old male ...". The Patient was 60 years old. (iii) The "Progress Note-Physician Endocrine f/u," FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 5 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 087 Continued From page 5 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 087 dated 4/27/18 stated, " ...Patient is a 58 year old status post heart transplant on 4/6/18." The patient was 60 years old and date of the heart transplant was 4/5/18. (iv) The "Progress Note -Physician Endocrine covg," dated 5/5/18 stated, " ...Age 60 years ...Patient is a 58 year old status post heart transplant on 4/6/18. ..." The patient was 60 years old and the date of the heart transplant was 4/5/18. b. Upon review of the medical record, the following conflicting documentation was revealed: (i) The "Progress Note-Physician," dated 4/6/18 at 5:16 AM, stated, " ...Intubated, has not woken up yet ... Neurological: Alert, oriented to time, place, and person. No focal neurological deficit." c. Upon review of the medical record, the following incomplete documentation was revealed: (i) The "Operative Report," dated 4/6/18 stated, "... DESCRIPTION OF OPERATION: ... the pulmonary pressure was /mm Hg [millimeters of Mercury], the arterial blood pressure was /mm Hg, the cardiac output was liters/minute and the cardiac index was liters/minute." X 093 QUALIFIED SOCIAL WORKER CFR(s): 482.94(d) X 093 AHO ALO A qualified social worker is an individual who meets licensing requirements in the State in which he or she practices; and (1) Completed a course of study with specialization in clinical practice and holds a master's degree from a FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 6 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 093 Continued From page 6 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 093 graduate school of social work accredited by the Council on Social Work Education; or (2) Is working as a social worker in a transplant center as of the effective date of this final rule and has served for at least 2 years as a social worker, 1 year of which was in a transplantation program, and has established a consultative relationship with a social worker who is qualified under (d) (1) of this paragraph This STANDARD is not met as evidenced by: Based on review of transplant social workers' personnel files and staff interview, it was determined that the facility failed to ensure that all hired social workers have one (1) year of experience in solid organ transplantation, as defined in the regulations as organs covered by Medicare, and receive transplant orientation upon hire in two (2) out of seven (7) social worker files reviewed (Staff #35 and Staff #36). Findings include: 1. Staff #35 and Staff #36's employee files lacked evidence of one (1) year of experience in a solid organ transplantation program, and transplant orientation upon hire or through their first year of employment. a. Staff #35's date of hire was 7/16/18. b. Staff #36's date of hire was 9/10/12. 2. Staff #2 confirmed the above during interview on 10/15/19 at 1:20 PM, and stated he/she does not think there is any other information related to Staff #35 and Staff #36's transplant experience FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 7 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 093 Continued From page 7 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 093 and orientation. X 099 QUALITY ASSESSMENT/PERFORMANCE IMPROVEMENT CFR(s): 482.96 AHO X 099 ALO Transplant centers must develop, implement, and maintain a written, comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all transplantation services, including services provided under contract or arrangement. This CONDITION is not met as evidenced by: Based on facility document review and staff interview, it was determined the AHO and ALO programs did not have a QAPI (Quality Assessment Performance Improvement) program that takes actions and provides staff education for improvement, following analysis of their adverse events and identification of areas for improvement. Findings include: 1. The facility failed to ensure it takes action that results in performance improvement. (Cross refer to Tag X 101) 2. The facility failed to ensure that performance improvement activities accurately track adverse patient events and analyze their cause throughout the hospital. (Cross refer to Tag X 103) 3. The facility did not ensure that adverse event analysis was used to effect changes and prevent repeat incidents. (Cross refer to Tag X 104) X 101 ACTIONS TO IMPROVE FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 X 101 Facility ID: NJTH00120 If continuation sheet Page 8 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 101 Continued From page 8 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 101 PERFORMANCE/TRACKING AHO ALO CFR(s): 482.96(a) The transplant center must take actions that result in performance improvements and track performance to ensure that improvements are sustained. This STANDARD is not met as evidenced by: Based on staff interview and document review, it was determined that the facility failed to take actions on recommendations from the Heart and Lung Transplant adverse event log which allowed subsequent adverse events to occur. This lack of action resulted in an Immediate Jeopardy for patients. Findings include: Reference: Facility document 'Performance Improvement Plan' states, "...II. Organization-wide Methodology... PLAN the improvement... Do the improvement... CHECK the results... Helpful Tools/Techniques: examine process, Monitoring processes, communication flow, policies and procedures, competency and educational needs..... ACT to hold the gain (initiate action permanently). Prevent the problem and its root causes from recurring. Implement policies, practice changes, education ..." 1. A review of the "Adverse Event Log - Lung Transplant Program 2019" revealed that Medical Record LR (Lung Recipient) #12 was identified as having an adverse event regarding equipment malfunction during a transplant that took place on 12/15/18. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 9 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 101 Continued From page 9 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 101 a. The documented outcome of the review indicated "Recommendation to use primed CBP (cardiopulmonary bypass) machine in the event of ECMO (extracorporeal membrane oxygenation) issues going forward. Perfusionists will be informed." (i) The facility was unable to provide evidence of education that took place with the perfusionists regarding the proposed recommendation for the adverse event of Medical Record LR #12. 2. There were two other identified issues with ECMO equipment contributing to patient adverse events, adverse event #4 and adverse event #7, that occurred after Medical Record LR #12's occurrence. a. Adverse event #4's documented outcome of the review following the patient's transplant that occurred on 2/19/19 indicated "Recommendation from the team to convert to CPB machine when issue with ECMO occurs. Team agrees and will communicate to other team members." b. Adverse event #7's documented outcome of the review following the patient's transplant that occurred on 4/19/19 indicated "Outcome of review: ... ECMO circuit with low flow and clotting. ..." c. An interview on 10/11/19 with Staff #20, a perfusionist, revealed that adverse event identifiers and recommendations may or may not be relayed to the perfusionists. Staff #20 indicated that there were not regularly scheduled meetings to discuss cases, and not everyone attends when there are meetings. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 10 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 101 Continued From page 10 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 101 3. The "Adverse Event Log - Heart Transplant Program 2018" indicated for adverse event #1, a transplant procedure that took place on 1/17/18, the outcome was "...Recommendation from the team: Have a 2nd (second) surgeon available for difficult and prolonged cases....."; This adverse event resulted in mortality for the patient. The "Adverse Event Log - Heart Transplant Program 2018" indicated for adverse event #8, a transplant procedure that took place on 5/2/18, the outcome was "... Plan to encourage transplant physicians to ask and offer assistance for difficult and lengthy cases ..." a. The facility was unable to provide evidence of physician education or monitoring for the above adverse events' recommendations. 4. The "Adverse Event Log - Heart Transplant Program 2018" was reviewed, and the following was identified: a. Adverse event #4, a transplant procedure that took place on 3/12/18 resulted in a neurological deficit. The outcome recommendation was "... Plan to review transducer level placement with correlation to cuff blood pressure for accuracy ..." (i) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. b. Adverse event #3, a transplant procedure that took place on 4/5/18 that resulted in a severe neurological deficit, the outcome recommendation was "...Plan to review transducer level placement with correlation to cuff blood pressure for accuracy ..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 11 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 101 Continued From page 11 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 101 (i) Adverse event #3 took place twenty-four (24) days after adverse event #4, and had the same outcome recommendations. (ii) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. c. The above findings were confirmed by Staff #21 and Staff #22. 5. The "Adverse Event Log - Heart Transplant Program 2018" and the "Adverse Event Log Lung Transplant Program 2018" were reviewed and the following was identified: a. Adverse event #20 on the heart transplant log was a transplant procedure that took place on 8/19/18 that resulted in renal failure requiring hemodialysis. The outcome and recommendation was, "...Opportunity for improvement regarding the frequency of blood pressure documentation the OR [operating room]. It is unknown whether the patient had periods of hypotension... Continuous monitoring equipment acquisition... perfusion to document BPs [blood pressures] every 15 min [minutes] vs [versus] every 30 min Surgeon to pause when patient placed on bypass to assess adequate BP." (i) The facility was unable to provide evidence of education to physicians and perfusionists, as well as monitoring for implementation of the above recommendations. b. Adverse event #22 on the heart transplant log was a transplant procedure that took place on 9/21/18, thirty-three (33) days after the heart transplant adverse event #20, that resulted in FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 12 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 101 Continued From page 12 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 101 altered mental status and a return to the OR. The outcome and recommendation was, "... Opportunities for improvement were suggested regarding the intraop [sic] management, specifically of blood pressure ..." Recommendations that were documented on the "Cardiothoracic Surgery Adverse Event Multidisciplinary Meeting" minutes from 10/19/18 indicated "... Increase the frequency of blood pressure monitoring and documentation in the OR ..." (i) The facility was unable to provide evidence of education or monitoring for implementation of the above recommendations. c. Adverse event #12 on the lung transplant log was a transplant procedure that took place on 10/10/18 that resulted in renal failure requiring hemodialysis "...likely due to hypotension in OR... ." The recommendation and monitoring as per the "Lung Transplant Program Adverse Event Multidisciplinary Meeting" minute from 11/27/18 was to "monitor for future occurrences." (i) The facility was unable to provide evidence of education or monitoring of the above recommendations. 6. Upon review of the medical record of Medical Record HR #11, the "Operative Report" written by Physician #25 noted, "... It was seen that the donor lung was oversized. For this reason an atypical wedge resection was carried out... the middel [sic] lobe was partially resected as well as the upper lobe. The procedure was continued with a left sided lung transplant. This was carreid [sic]out by [Physician #73] in the same technique ..." FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 13 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 101 Continued From page 13 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 101 a. A review of the Lung Transplant Program "Adverse Event Multidisciplinary Meeting" that took place on 11/27/18, identified adverse events that took place during the transplant process for Medical Record HR #11. The 'Recommendations/Action' noted that the "Multidisciplinary team discussed the case at length" and the 'Monitor/Follow-Up' was to "Monitor for future occurrences." (i) The Lung Transplant Program "Adverse Event Multidisciplinary Meeting" minutes lacked evidence of the mismatched donor lung size and resulting intra-operative resections. 7. An interview with Staff #21 and Staff #22 revealed that there was no documented evidence to support the tracking and monitoring of the above adverse events to prevent reoccurrences. 8. The facility was notified of the IJ on December 12, 2019 at 2:34 PM. X 103 ANALYSIS/DOCUMENTATION OF ADVERSE EVENT CFR(s): 482.96(b)(2) AHO X 103 ALO The transplant center must conduct a thorough analysis of and document any adverse event . This ELEMENT is not met as evidenced by: Based on staff interview and document review, it was determined that the facility failed to accurately document the adverse events to ensure tracking and analysis for its Quality Assessment and Performance Improvement (QAPI) activities. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 14 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 103 Continued From page 14 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 103 Findings include: Reference: Facility document 'Performance Improvement Plan' states, "...V. Program Goals ...2. Transform data into useable information that identifies process stability or predictability in relationship to performance expectations ..." 1. A review of the "Adverse Event Log - Lung Transplant Program 2018" revealed the following documentation inaccuracies: a. Adverse event #12 had a Medical Record (MR) number that did not identify a transplant patient. (i) Staff #2 confirmed that the MR number was incorrect. 2. A review of the "Adverse Event Log - Lung Transplant Program 2019" revealed the following documentation inaccuracies: a. Adverse event #1 indicated a transplant date of 12/15/19. (i) Staff #2 confirmed that the transplant date was incorrect and should have been written as 12/15/18. b. Adverse event #2 indicated a transplant date of 7/3/1905. (i) Staff #2, confirmed that the transplant date was incorrect. c. Adverse event #8 indicated that the outcome of the event was mortality. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 15 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 103 Continued From page 15 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 103 (i) The MR number that was documented as adverse event #8 was for a patient that was currently in the hospital. (ii) Staff #2 confirmed that the MR number was incorrect for adverse event #8. X 104 EFFECT CHANGES TO PREVENT REPEAT INCIDENTS CFR(s): 482.96(b)(2) AHO X 104 ALO The transplant center must utilize the adverse event analysis to effect changes in the transplant center's policies and practices to prevent repeat incidents. This ELEMENT is not met as evidenced by: Based on staff interview and document review, it was determined that the facility did not ensure that an adverse event analysis is used to effect changes and prevent repeat incidents. Findings include: Reference: Facility document "Performance Improvement Plan" states, "...II. Organization-wide Methodology... PLAN the improvement... Do the improvement... CHECK the results... Helpful Tools/Techniques: examine process, Monitoring processes, communication flow, policies and procedures, competency and educational needs..... ACT to hold the gain (initiate action permanently). Prevent the problem and its root causes from recurring. Implement policies, practice changes, education ..." 1. A review of the "Adverse Event Log - Lung Transplant Program 2019" revealed that Medical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 16 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 104 Continued From page 16 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 104 Record LR #12 was identified as having an adverse event regarding equipment malfunction during a transplant that took place on 12/15/19. a. The documented outcome of the review indicated "Recommendation to use primed CBP (cardiopulmonary bypass) machine in the event of ECMO (extracorporeal membrane oxygenation) issues going forward. Perfusionists will be informed." (i) The facility was unable to provide evidence of education that took place with the perfusionists regarding the proposed recommendation for the adverse event of Medical Record LR #12. (ii) There were two other identified issues with ECMO equipment contributing to patient adverse events, adverse event #4 and adverse event #7, that occurred after Medical Record LR #12's occurrence. (iii) An interview on 10/11/19 with Staff #20, a perfusionist, revealed that adverse event identifiers and recommendations may or may not be relayed to the perfusionists. Staff #20 indicated that there were not regularly scheduled meetings to discuss cases, and not everyone attends when there are meetings. 2. The "Adverse Event Log - Heart Transplant Program 2018" indicated for adverse event #1, a transplant procedure that took place on 1/17/18, the outcome was "...Recommendation from the team: Have a 2nd (second) surgeon available for difficult and prolonged cases....."; This adverse event resulted in mortality for the patient. The "Adverse Event Log - Heart Transplant Program 2018" indicated for adverse event #8, a transplant FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 17 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 104 Continued From page 17 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 104 procedure that took place on 5/2/18, the outcome was "... Plan to encourage transplant physicians to ask and offer assistance for difficult and lengthy cases ..." a. The facility was unable to provide evidence of physician education or monitoring for the above adverse events' recommendations. 3. The "Adverse Event Log - Heart Transplant Program 2018" was reviewed, and the following was identified: a. Adverse event #4, a transplant procedure that took place on 3/12/18 resulted in a neurological deficit. The outcome recommendation was "... Plan to review transducer level placement with correlation to cuff blood pressure for accuracy ..." (i) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. b. Adverse event #3, a transplant procedure that took place on 4/5/18 that resulted in a severe neurological deficit, the outcome recommendation was "...Plan to review transducer level placement with correlation to cuff blood pressure for accuracy ..." (i) Adverse event #3 took place twenty-four (24) days after adverse event #4, and had the same outcome recommendations. (ii) The facility was unable to provide evidence of the review and monitoring of the transducer level placement and blood pressure cuff correlation. c. The above findings were confirmed by Staff FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 18 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 104 Continued From page 18 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 104 #21 and Staff #22. 4. The "Adverse Event Log - Heart Transplant Program 2018" and the "Adverse Event Log Lung Transplant Program 2018" were reviewed and the following was identified: a. Adverse event #20 on the heart transplant log was a transplant procedure that took place on 8/19/18 that resulted in renal failure requiring hemodialysis. The outcome and recommendation was "...Opportunity for improvement regarding the frequency of blood pressure documentation the OR [operating room]. It is unknown whether the patient had periods of hypotension... Continuous monitoring equipment acquisition... perfusion to document BPs [blood pressures] every 15 min [minutes] vs [versus] every 30 min - Surgeon to pause when patient placed on bypass to assess adequate BP." (i) The facility was unable to provide evidence of education to physicians and perfusionists, as well as monitoring for implementation of the above recommendations. b. Adverse event #22 on the heart transplant log was a transplant procedure that took place on 9/21/18, thirty-three (33) days after the heart transplant adverse event #20, that resulted in altered mental status and a return to the OR. The outcome and recommendation was "... Opportunities for improvement were suggested regarding the intraop [sic] management, specifically of blood pressure ..." Recommendations that were documented on the "Cardiothoracic Surgery Adverse Event Multidisciplinary Meeting" minutes from 10/19/18 indicated, "... Increase the frequency of blood FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 19 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 104 Continued From page 19 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 104 pressure monitoring and documentation in the OR ..." (i) The facility was unable to provide evidence of education or monitoring for implementation of the above recommendations. c. Adverse event #12 on the lung transplant log was a transplant procedure that took place on 10/10/18 that resulted in renal failure requiring hemodialysis ... likely due to hypotension in OR....." The recommendation and monitoring as per the "Lung Transplant Program Adverse Event Multidisciplinary Meeting" minute from 11/27/18 was to "monitor for future occurrences." (i) The facility was unable to provide evidence of education or monitoring of the above recommendations. 5. Upon review of the medical record of Medical Record HR #11, the "Operative Report" written by Physician #25 noted, "... It was seen that the donor lung was oversized. For this reason an atypical wedge resection was carried out... the middel [sic] lobe was partially resected as well as the upper lobe. The procedure was continued with a left sided lung transplant. This was carreid [sic] out by [Physician #73] in the same technique ..." a. A review of the Lung Transplant Program "Adverse Event Multidisciplinary Meeting" that took place on 11/27/18, identified adverse events that took place during the transplant process for Medical Record HR #11. The 'Recommendations/Action' noted that the "Multidisciplinary team discussed the case at length" and the 'Monitor/Follow-Up' was to FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 20 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 104 Continued From page 20 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 104 "Monitor for future occurrences." (i) The Lung Transplant Program "Adverse Event Multidisciplinary Meeting" minutes lacked evidence of the mismatched donor lung size and resulting intra-operative resections. 6. An interview with Staff #21 and Staff #22 revealed that there was no documented evidence to support the tracking and monitoring of the above adverse events to prevent reoccurrences. X 149 PATIENT AND LIVING DONOR RIGHTS CFR(s): 482.102 X 149 AHO ALO In addition to meeting the condition of participation "Patients Rights" requirements at §482.13, the transplant center must protect and promote each transplant patient's and living donor's rights. This CONDITION is not met as evidenced by: Based on document review, staff interview, and medical record review, it was determined that the facility failed to protect and promote each transplant patient's rights for confidentiality of protected Health Information (PHI), for receiving an explanation of each patient's medical condition, and for informed consent. Findings include: 1. Review of a published newspaper article, interviews, and review of facility policies and procedures, revealed facility staff did not maintain patients' rights to confidentiality of their clinical record and Protected Health Information (PHI). FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 21 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 21 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 Reference #1: Facility Policy #P-10, titled "Patient Rights" states, "... POLICY: ... 2. Patient's rights are set forth by Federal and State regulatory agencies. All hospital staff adopts and promotes patient rights. Patient's Rights are as follows: ... Medical Records [bullet] To the confidentiality of your clinical record and protected health information. ..." Reference #2: Facility Policy # H-11, titled "Basic Uses and Disclosure of Patient Information" states, "... DEFINITIONS: Protected Health Information" or "PHI" as used in all the Facility's I-IIPAA (sic) policies, is information, in any form or medium (including oral, written and electronic communications), that is created by the Facility, another healthcare provider or a health plan, and relates to an individual's physical or mental health (provision of payment for) and identifies, or could be reasonably expected to be used to identify, an individual. ... Examples of PHI include a patient's name, address, telephone number, diagnosis, date of birth, age over 90, and/or date of service as well as any and all other identifying information found in the patient's clinical and billing records. POLICY: Employees, volunteers and members of the Medical Staff of the Facility must maintain the confidentiality and privacy of patient information in accordance with the Health Information Portability and Accountability Act of 1996 ("HIPAA") ... In sum, HIPAA requires the Facility to adhere to certain rules, as set forth below. PROCEDURES: I. GENERAL RULES ... B. Other uses and disclosures of PHI. The Facility will not use or disclose PHI for purposes other than treatment, payment and health care operations, ..." Reference #3: Facility Policy #M-14, titled "Medical Records Confidentiality, Security, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 22 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 22 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 Availability and Retention" sates, "... PURPOSE: To ensure the confidentiality, security, availability and retention of medical records. ... The information contained in the medical record belongs to the patient, which entitles the patient to the protected right of information. All patient care information shall be regarded as confidential and available only to authorized users. ..." a. A newspaper article, published on 10/3/19 by nj.com, found at https://www.nj.com/news/2019/10/nj-hospital-kept -patient-on-life-support-for-months-to-boost-its-su rvival-rates-investigation-reveals.html, identifies patients' Protected Health Information (PHI) within the content of the article, and references a recording of a meeting among surgeons, cardiologists, transplant coordinators, nurses, and social workers, in which patients at the facility were discussed. Per documentation in the article, "... This story is based on medical records, emails and text messages, and interviews with family members as well as eight (8) current and former staff at Newark Beth Israel, who spoke on the condition of anonymity for fear of jeopardizing their jobs or future employment in the field. The recordings were corroborated by staff members present during those discussions and verified the identities of the speakers." b. The eight (8) facility staff members violated the patients' rights by not maintaining the confidentiality and privacy of patient information and sharing the patients' PHI with the news reporter(s) for purposes other than treatment, payment and health care operations. c. On 10/17/19 at 1:07 PM, during a telephone interview with Patient HR #5's family member, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 23 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 23 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 he/she stated that he/she and his/her family have a transcript of the audio recording of the transplant team meeting referred to in the above article that was provided to them by the newspaper reporter. Reference #4: Facility Policy #Comp 12, titled, "Compliance Helpline" states, "PURPOSE: To maintain a Compliance HelpLine (sic) Program which allows employees to report compliance and business ethics issues, questions, or concerns, to the Compliance Department and provides for investigation and resolution of such issues, questions or concerns. ... POLICY: --[facility's corporate system name]-- and its affiliates shall maintain 24-hour toll-free telephone line (Compliance HelpLine (sic) Program) enable individuals to make disclosures to the Compliance Department. Such disclosures may include any issues, questions or concerns identified by or associated with the Systems Code of conduct, policies and procedures, practices, ... The Compliance HelpLine (sic) Program shall emphasize a non-retribution, non-retaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. ..." Reference #5: Facility Policy #E-2, titled, "Ethics Consultation Service" states, "... POLICY: 1. The Bioethics Consultation service may be utilized 24 hours per day, 7 days per week, and 365 days per year. Consults may be requested by any member of the staff, the patient, or a family member or friend. Consults may be made anonymously. Common reasons for consultation include the following but this is by no means an exhaustive list: a. conflicts regarding end of life care... c. Professional just conduct ... FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 24 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 24 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 PROCEDURE: 1. When an existing or potential ethical dilemma regarding patient care is identified by a health care team member, patient, family members, or caregiver, resolution should be first attempted by the interested parties. ... 2. If there is unsuccessful resolution of the dilemma among the interested parties, the initiator contacts the hospital operator for the on-call ethics consultant of the Ethics Consultation Service Team. Permission for an ethics consultation from any member of the health care team is not required. ..." Reference #6: Facility Policy #C-26, titled "Code of Ethics" states, "... Procedure: ... VI. Resolution of Conflict or Ethical Issues: Hospital Staff should seek guidance from appropriate sources, within the organization when any type of ethical question or conflict arises. ... XI. Confidentiality: The Hospital recognizes the importance of maintaining patient and other business related information in a confidential manner. ..." d. The Employee Complaint and Grievance process and meeting minutes were reviewed. The facility provided documentation of employee complaints from January 2018 to date, along with their resolutions. The facility followed their process for employee complaints. There was no evidence of reported concerns regarding the care of transplant patients within the Employee Complaint and Grievance meeting minutes. e. The Ethics Committee Meeting minutes were reviewed. There was no evidence of reported concerns regarding transplant patients within the ethics committee meeting minutes. f. There was no evidence that any staff member FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 25 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 25 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 sought guidance from sources within the organization with their concerns about the care and management of transplant patients post operatively, as per facility policies and procedures. (i) Staff #2 confirmed the above during the survey and during a telephone call on 11/14/19 at 3:00 PM. 2. Medical record review and review of facility policies, revealed all patients or their next of kin did not receive an explanation of their complete medical condition from a physician, in accordance with facility policies. Reference #1: Facility Policy #P-10, revised 1/2019, titled "Patient Rights" states, "... POLICY: ... 2. Patient's rights are set forth by Federal and State regulatory agencies. All hospital staff adopts and promotes patient rights. Patient's Rights are as follows: ... Medical Care ... [bullet] To receive an understandable explanation from your physician of your complete medical condition, recommended treatment, expected results, risks involved, and reasonable alternatives. If your physician believes that some of this information would be detrimental to your health or beyond your ability to understand, the explanation must be given to your next of kin or guardian. ..." Reference #2: Facility Policy #C5, titled "Communication with Family by Physicians and Nursing Staff" states, "Purpose: This policy will define the role of the Licensed Independent Practitioner (LIP) and nurse in communicating with family members. This communication includes the notification of family when the patient FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 26 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 26 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 is admitted to the hospital and the ongoing communication regarding the patient's progress/condition as well as changes in patient condition. ... Licensed Independent Practitioner's responsibilities: [bullet] The LIP will contact the patient's family or representative promptly in most cases within 24 hours after admission [bullet] Informing them of the general condition of the patient and of any treatment that may be performed [bullet] Thereafter, the LIP will contact the family or representative on a regular basis regarding the progress of the patient throughout the hospital stay ... [bullet] Communication with the patient's family will be documented on the Progress Notes in the Electronic Medical Record ..." a. Review of Medical Record HR #4 revealed the patient was admitted to the facility on 2/9/19. A physician progress note, dated 3/17/19, stated that the patient's "... Prognosis is not great." b. A Social Work note, dated 4/29/19, revealed a family meeting was held with Medical Record HR #4's next-of-kin and physicians overseeing his/her care. The patient's respiratory status was discussed, and the family member asked that he/she be updated if the patient's medical condition deteriorated further and be kept up to date weekly. (i) There was no documented evidence in the medical record that the physicians updated the patient's next-of-kin that his/her prognosis was "not great." c. A Social Work note, dated 5/23/19, revealed that the social worker met with Medical Record HR #4's next-of-kin. "The patient's next of kin was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 27 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 27 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 contacted "yesterday" [5/22/19] to provide consent for a LP [lumbar puncture] procedure, which ended up not happening because the patient desaturated [oxygen saturation decreased]. The procedure was canceled and the next of kin was not called by the medical team after this event occurred. The patient's next of kin "... has also not received weekly updates from the primary medical team, which --[he/she]-requested some weeks ago. ... they only call ... to ask permission to perform "test after test". The social work note reveals the next of kin "... understands that [his/her] overall prognosis is poor." and that [he/she] "... does not believe that pt [patient] would want to live in this condition and that it may be time for [him/her] to go be (sic) in the afterlife ..." d. Physician's progress notes, dated 6/7/19 and 6/9/19 each stated that Medical Record HR #4's "... Overall prognosis is poor." On 6/13/19, a physician's progress note stated, "... -Guarded overall prognosis." (i) There was no documented evidence in the medical record that the physicians updated the patients next-of-kin that his/her prognosis was poor or guarded at the time. e. The following Social Work notes were evident in Medical Record HR #4: (i) A Social Work note, dated 7/2/19, stated, "... Goals of care discussion with pt's [patient's] family will continue to be encouraged of the medical team as this has not yet occurred; ..." (ii) A Social Work note, dated 7/24/19, revealed a meeting was held with Medical Record HR #4's FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 28 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 28 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 next-of-kin, a social worker, and a cardiologist. The patient's next-of-kin asked the social worker "... if [he/she] still requires such a high level of care. ... Dr. --- arrived ... In the first goals of care discussion since pt suffered anoxic brain injury during [his/her] heart transplant Sept/2018 (more than 10 months ago), Dr. --- briefly discussed ... questions and spoke ... about pt's unchanged condition, ... [He/She] [the physician] asked ... if [he/she- next of kin] would consent to proceeding with a TEE [Transesophageal echocardiogram] ... Pt.'s [next of kin] stated ... is amenable to continue diagnostic tests for now. ..." (iii) A Social work note, dated 7/31/19, revealed the patient's next-of-kin asked about the results of the TEE that was completed last week. The next-of-kin stated he/she was contacted by a provider to give consent for the procedure and the next-of-kin asked that someone call with the results. Per the social work note, the next-of-kin never received a call. f. The medial record lacked documented evidence that the physicians contacted Medical Record HR #4's next-of-kin on a regular basis, or a weekly basis as requested, regarding the progress of the patient throughout his/her hospital stay, as per facility policy. 3. Review of Medical Record HR #5's postoperative medical record lacked evidence of communication with the patient's family regarding his/her status, treatment, and plan of care from 4/9/18 to 4/20/18. a. The "Progress Note-Physician" dated 4/7/18 states, " ... not neurologically appropriate at this time ... Gaze to the left and up (looking at the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 29 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 149 Continued From page 29 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 149 lesion?) Alternatively, [he/she] is just still sedated by all of the anesthesia and the shaking is waking [him/her] up. ... Not sure whether there is reason to be concerned or not yet ..." b. The "Consultation Note Neurology" dated 4/8/18 states, " ... abnormal head CT [computerized tomography] ... EEG [electroencephalogram] -non conclusive status epilepticus ... discussed results with multiple family members ..." c. The "Progress Note -Physician ...Neurology Follow-up" dated 4/21/18, states, " ... had MRI [magnetic resonance imaging] of the brain. ... Opens eyes but not following command, not verbal ... not withdrawing to pain ... Course: MRI of the brain showed punctate strokes, likely septic emboli ... discussed with family. ..." 4. The facility failed to ensure all informed surgical consents are completed per facility policy prior to surgery. (Cross refer to Tag X 152). X 152 PATIENT INFORMED OF SURGICAL PROCEDURE CFR(s): 482.102(a)(2) AHO X 152 ALO Each patient is informed of the surgical procedure. This ELEMENT is not met as evidenced by: Based on medical record review, staff interview, and review of facility policies, it was determined that the facility failed to ensure all informed surgical consents are completed per facility policy prior to surgery in eight (8) of eleven (11) medical records reviewed for informed consents (Medical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 30 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 30 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 Records #2, #4, #5, #8, #9, #11, #12, and #15). Findings include: Reference #1: Facility Policy # I-1, titled "Consent, Informed" states,"... POLICY: ... 1. Prior to any Procedure, the Physician must obtain informed consent to be valid, it must be the result of an informed decision making process. In addition, the Physician must provide the patient or Surrogate Decision Maker necessary information to enable him/her to evaluate a proposed Procedure before agreeing to it. ... 2. The licensed physician, ... has the knowledge to discuss and disclose the nature, risks, benefits and alternatives for Procedures requiring informed consent and answer any resulting questions before the licensed physician begins any such course of treatment. ... the discussion between Physician and patient or Surrogate Decision Maker as part of the informed consent process must include: ... b) Potential benefits of the proposed procedure to the patient. c) Potential short and longer term risks, or side effects, including potential problems that might occur during recuperation. ... e) Reasonable alternative methods of treatment, including relevant risks, benefits and side effects of the alternatives. f) The possible results of declining the recommended Procedure. ... II. INFORMED CONSENT: ...4. A properly executed informed consent must contain at least the following: ...i) ...- The patient shall be notified if Physicians other than the operating practitioner, including but not limited to residents, may perform important tasks related to surgery in accordance with hospital policy. ... VIII. TELEPHONE OR FAX CONSENT OF SURROGATE DECISION MAKER: ... 2. The Physician should have a licensed clinical FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 31 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 31 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 professionals (sic) (RN, NP, PA), to witness the informed consent discussion when given by telephone. The licensed staff members must listen to the phone conversation at the same time. ... 4. The informed consent of the Surrogate Decision Maker shall be recorded on the consent form and witnessed by both persons hearing the consent given. ... 5. It is not always possible that the physician discussion of informed consent with a Surrogate Decision maker is done in the presence of a nurse. In circumstances when the registered nurse does not hear the actual disclosure, two (2) licensed professional need to confirm with the physician that the discussion of informed consent took place. Both licensed professionals (one who must be an RN) need to sign the informed consent form indicating that they received such confirmation. ..." Reference #2: Facility Policy #02, titled, "Multidisciplinary Team Roles in all Phases of Transplant" states, "... Multidisciplinary Team Roles and Responsibilities ... Transplant Surgeon ... [bullet] Transplant Phase responsibilities include but are not limited to obtaining informed consent for transplant surgery, ..." 1. Multiple medical records for Medical Record HR #4 were reviewed for admissions and out patient visits from March 2014 to October 2019. The following consent forms were not completed in accordance with facility policy: a. The patient signed a consent on 3/28/14 at 5:25 PM for a swanz ganz catheter and arterial line, that was also signed by a physician and witnessed. The area for the alternative procedures was blank and had no documentation to indicate the information was provided to the FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 32 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 32 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 patient, to ensure an informed decision was made prior to his/her signature. b. Medical Record HR #4 contained a consent for colonoscopy, signed by the patient and physician, and witnessed by a nurse on 4/14/2014. The consent lacked evidence that alternative procedures for the colonoscopy were discussed. This area on the consent was blank. c. The patient signed a consent for anesthesia on 4/7/14 at 3:35 PM, however, the anesthesiologist and witness did not sign until 4/8/14 at 8:15 AM. The consent was signed by the patient prior to the anesthesiologist explaining the "... route of administration and its effects and possible complications associated with anesthesia ..." d. The patient had a right Heart Catheterization outpatient procedure on 1/30/17. Page 2 of the consent, that contained the area of patient signature for informed consent, was not evident in the medical record; therefore, it could not be determined if the patient gave his/her informed consent. Staff #59 confirmed via e-mail on 11/5/19 and via telephone on 11/6/19, that the facility was unable to locate page 2 of the informed consent. e. A telephone consent from the patient's Surrogate Decision Maker (SDM), dated 9/27/18, for a tracheotomy lacked evidence of a second signature witnessing the telephone consent, as per facility policy. (i) Staff #59 confirmed during interview on 10/16/19 that there should be a second nurse signature for this consent. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 33 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 33 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 2. Medical Record HR #5 contained a consent dated 4/5/18, that was signed by the patient, the surgeon, and witnessed by a registered nurse (RN) at 12:42 PM. The areas for the proposed procedure, alternative procedures, and benefits and risks of the proposed procedure were blank and there was no documentation to indicate the information was provided to the patient, to ensure an informed decision was made prior to his/her signature. a. Review of the intra-operative notes and the surgeon's operative report indicated the patient's surgery completed on 4/5/18 included a heart transplant, re-do sternotomy, removal of an ICD [internal cardiac defibrillator] and removal of an LVAD [left ventricular assist device]. b. The "Anesthesia Consent" was obtained on 4/5/18. The "Disclosure of Exceptions to Anesthesia (by patient of physician), if any, are" was not completed. c. The above findings were confirmed by Staff #59. 3. Medical Record HR #9 contained a consent dated 3/12/18 for a heart transplant. The area for alternative procedures was blank and contained no documentation to indicate the information was provided to the patient, to ensure an informed decision was made prior to his/her signature. 4. Medical Record HR #15 contained a consent for a trans-esophageal echocardiogram procedure dated 10/17/19 that was signed by the patient's SDM, the surgeon, and witnessed by a nurse at 7:23 AM. The area for alternative FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 34 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 34 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 procedures was blank and contained no documentation to indicate the information was provided to the patient's SDM, to ensure an informed decision was made prior to his/her signature. 5. Upon review of Medical Record LR #2 on 10/10/19, the following was revealed: a. The "Consent To Surgical Procedures Flexible Bronchoscopy" was obtained on 9/22/19. (i) The "Condition requiring treatment:" stated, "...explained to me that the following conditions appear to exist in my case:" was not completed. b. The "Consent To Surgical Procedures" was obtained for a percutaneous tracheostomy on 9/23/19. (i) The "Condition requiring treatment:" stated, "...explained to me that the following conditions appear to exist in my case:" was not completed. c. The "Consent For Lung Transplant Surgical Procedures" was obtained on 10/1/19. (i) The "Condition requiring treatment:" stated, "...explained to me that the following conditions appear to exist in my case:" was not completed. 6. Upon review of Medical Record HR #8 on 10/10/19, the following was revealed: a. The "Consent To Surgical Procedures" was obtained for a trialysis catheter on 10/3/19. (i) The "Condition requiring treatment:" stated, "...explained to me that the following conditions FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 35 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 35 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 appear to exist in my case:" was not completed. 7. Upon review of Medical Record LR #12 on 10/11/19 and 10/15/19, the following was revealed:. a. The "Consent for Administration of Blood and Blood Products" was obtained on 9/30/19. (i) Section 1. "...recommended the following blood or blood product(s):" was not completed. b. An "Anesthesia Consent" was obtained on 10/19/19. (i) The "Alternative types of anesthesia are" was not completed. (ii) The "Disclosure of Exceptions to Anesthesia (by patient or physician), if any, are:" was not completed. c. A consent, dated 10/11/19, for a sternal wound washout, possible hard-wire insertion, and possible wound closure was found in the medical record. The area for alternative procedures was blank and contained no documentation to indicate the information was provided to the patient, to ensure an informed decision was made prior to his/her signature. 8. Upon review of Medical Record HR #11, the following was revealed: a. The "Consent to Surgical Procedures" was obtained by Physician #73 for a "B/L (bilateral) thoracotomy, double lung transplantation, and a re-exploration of bleeding" on 10/10/18 at 5:20 PM. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 36 of 37 PRINTED: 12/12/2019 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED A. BUILDING ______________________ C 319803 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 201 LYON AVENUE AT OSBORNE TERRACE NEWARK BETH ISRAEL MEDICAL CENTER (X4) ID PREFIX TAG 10/18/2019 NEWARK, NJ 07112 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) X 152 Continued From page 36 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE X 152 (i) The "Condition requiring treatment:" stated, "...explained to me that the following conditions appear to exist in my case:" was not completed. b. The "Consent For Lung Transplant Surgical Procedures" was obtained by Physician #25 on 10/10/18 at 7:20 PM for "Lung Transplant (take out diseased lungs and replace with donor lungs), possible extracorporeal membrane oxygenation (ECMO), possible tracheostomy." (i) The "Condition requiring treatment:" stated, "...explained to me that the following conditions appear to exist in my case:" was not completed. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: WFUE11 Facility ID: NJTH00120 If continuation sheet Page 37 of 37